FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Trabecular Metal acetabular revision system buttress augment size, 58, 00-4898-001-58, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.
- Recall number
- Z-2215-2010
- Recalling firm
- Zimmer Inc.
- Product
- Trabecular Metal acetabular revision system buttress augment size, 58, 00-4898-001-58, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.
- Status
- Terminated
- Initiated
- 2010-04-06
- Posted
- 2010-08-12
- Terminated
- 2011-10-21
- Reason
- The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches.
- Root cause
- Packaging
- Action
- The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131.
- Quantity
- 1972 all products
- Distribution
- US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland.
- Lot, serial or model codes
- 60492195, 60531077, 60530963, 60661414, 60712297, 60770942, 60796674, 60834367, 60990646 and 61324530.
- 510(k) numbers
- ["K061067"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28